- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07934680
Mental Health Link for Veterans Referred to Mental Health Services (MHL)
Mental Health Link: Text Based Support for Veterans Waiting to Initiate Mental Health Services for Depression
Overview:
Depression is common among Veterans. About 1 in 6 Veterans experiences depression at any given time, and about half may experience it during their lifetime. Without treatment, depression can contribute to substance use, poor health, suicide, and early death. However, many people delay or do not receive treatment. Fewer than one-third of Veterans with depression use psychotherapy. Although the VA is working to improve access to mental health care, staffing shortages can lead to long wait times. These waiting periods may provide an opportunity to support Veterans and help them prepare for treatment.
Mental Health Link:
The research team developed Mental Health Link (MHL), a text-based process that supports Veterans while they wait for mental health services. MHL helps patients better understand their emotions and symptoms and offers simple coping strategies they can use right away while waiting.
Study Goals:
The study will examine whether MHL helps Veterans during the wait period and with treatment engagement. The study will also ask Veterans and providers about what helps or prevents MHL from being used in routine care.
Study Design:
Over five years, the study will compare MHL with usual care at three VA sites. It will include 192 Veterans referred to psychotherapy for depression. The results will show whether MHL improves participation in treatment and helps Veterans while they wait for services.
In the future, these findings may help the VA expand MHL and other effective mental health and suicide-prevention services.
연구 개요
상세 설명
Background: Depression is one of the most prevalent mental health concerns among Veterans. Nearly 1 in 6 Veterans has the disorder at any given time and 50% of Veterans meet criteria for depression at some point in their lives. Depression is associated with significant adverse outcomes, and untreated can result in drug abuse, poor health outcomes, suicide and other-cause mortality. Adults with depression often delay and underutilize treatment, and such delays in care are associated with low treatment utilization.
Significance: Psychotherapy utilization rates for depression among Veterans over the past two decades have stayed below 34%. VHA has organizational priorities to decrease system barriers through various strategies. Despite these efforts, the VHA has a critical national staffing shortage. Fortunately, mental health visit wait times can be leveraged as an opportune moment to support and prepare Veteran patients for upcoming visits. Currently, there are no tools to provide support to Veterans while they wait for mental health services.
Innovation and Impact: To address this gap in care, our team developed and pilot-tested Mental Health Link (MHL),an innovative solution that does not rely on reducing wait times, but rather leverages wait times to provide support and prepare Veterans for care. MHL is a semi-autonomous text-based tool designed to improve emotional and symptom awareness, and provide support during wait periods through sharing easy to implement coping strategies.
Specific Aims. Aim 1: Determine the effect of MHL on psychotherapy initiation and adherence (number of sessions completed). Aim 2: Determine the effect of MHL on emotional awareness, a sense of connectedness, and satisfaction with the VA and mental health service. Aim 3: Identify determinants, strategies, and perceived outcomes in a subsample of MHL users (n = 24) and their providers (n = 24) to inform an implementation research logic model and intervention mapping.
Methodology: The investigators propose a 3-site, 5-year mixed-method hybrid I randomized control trial (RCT) using an altered Zelen design to compare MHL to usual care in a sample of Veterans (N = 192) referred to psychotherapy for depression. In Aim 1, the investigators will employ logistic regression and poison regression to estimate the difference between the intervention and control groups in treatment initiation rates and number of sessions (i.e., treatment adherence), respectively. In Aim 2, the investigators will employ repeated measures MANCOVAs to test for the interaction between time and group on proposed outcomes: positive and negative emotional awareness, sense of connectedness and satisfaction. For Aim 3 the investigators will use a qualitative matrix-analysis framework to analyze focus group data to identify other factors related to Aims 1 and 2 outcomes for triangulation and key determinants of implementation of MHL into clinical flow. Next Steps/Implementation. By identifying determinants of implementation the investigators will target facilitators and barriers to integrate MHL into the mental health service workflow. This work will also provide evidence of effectiveness outcomes. Overall, findings will facilitate the development of a follow-up Merit, Type II Hybrid RCT, focused on implementation and effectiveness outcomes. In the long-term, this work will support the implementation and sustainment of evidence-based mental health and suicide prevention practices by optimizing access to care, using value-based care systems.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Vanessa Panaite, PhD
- 전화번호: (813) 768-2193
- 이메일: vanessa.panaite2@va.gov
연구 연락처 백업
- 이름: Lisa M Ballistrea, MPT DPT BS
- 전화번호: (813) 558-7637
- 이메일: Lisa.Ballistrea@va.gov
연구 장소
-
-
Colorado
-
Aurora, Colorado, 미국, 80045-7211
- Rocky Mountain Regional VA Medical Center, Aurora, CO
-
연락하다:
- Christine Melillo, PhD
- 이메일: Christine.Melillo@va.gov
-
-
Florida
-
Tampa, Florida, 미국, 33612
- James A. Haley Veterans' Hospital, Tampa, FL
-
연락하다:
- Shannon Miles, PhD
- 이메일: Shannon.Miles@va.gov
-
-
Illinois
-
Hines, Illinois, 미국, 60141-3030
- Edward Hines Jr. VA Hospital, Hines, IL
-
수석 연구원:
- Vanessa Panaite, PhD
-
연락하다:
- Julie F McMahon-Grenz, MS BS
- 전화번호: (813) 339-3050
- 이메일: Julie.McMahon-Grenz@va.gov
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-Veterans who receive a referral to psychotherapy for depression in a specialty care clinic (i.e., Mental Health Clinic at the VA or through VA Community Care)
Exclusion Criteria:
- Have current suicidal ideation with intent of self-harm in the last week
- Have current homicidal ideation with plans to hurt a specific person or have a clinical flag for disruptive behavior in their chart
- Have visual impairment that will impact completion of self-reports
- Have current diagnoses of bipolar disorders, psychotic disorders, memory and cognitive disorders
- Have referrals only to psychiatry or to a substance use disorder clinic
- Are hospitalized, in order to focus on their intensive care
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Mental Health Link (MHL)
Participants receive the fully automated MHL intervention through VA Qualtrics while awaiting their first specialty mental health appointment. Following the baseline survey, a welcome text activates twice-weekly check-ins and twice-weekly support messages until two days before the appointment. Check-ins collect patient-generated feedback on mood, PHQ-8 symptoms, daily event appraisals, emotions, and emotion intensity. Participants may skip any task. Support messages provide practical coping strategies. PHQ-8 scores ≥15 or heightened negative emotions trigger automated messages with contact information for the participant's existing care providers, the Veterans Crisis Line (call, chat, or text), and 911. At completion, a data manager prepares a summary of check-in data, uploads it to the medical chart, and alerts the participant's providers. |
Mental Health Link (MHL) is a text-based process that supports Veterans with depression while they wait to begin mental health care. Twice a week, it helps Veterans check in on daily events, emotions, and depression symptoms while offering brief, practical coping strategies based on evidence-based therapies, including cognitive behavioral therapy, behavioral activation, and acceptance and commitment therapy. MHL was tailored with input from Veterans to improve emotional awareness and monitor changes in symptoms. |
|
간섭 없음: Usual Care Control
Veterans assigned to this control arm receive usual care while awaiting their initial specialty mental health appointment. They may passively wait or receive psychiatric care or brief supportive psychotherapy through primary care. Half of the Veterans randomized to usual care will be invited to join an observational study examining their experiences with and use of mental health services. These participants will complete baseline and exit surveys to improve prediction and understanding of treatment initiation and utilization, because medical chart data alone have not produced robust predictive models. All study procedures are conducted for research purposes only, although the procedures and measures are similar to those used in standard mental health care. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Effectiveness of Intervention as Assessed by Rate of Depression Treatment Initiation
기간: An average of 30 weeks
|
The investigators will evaluate % mental health treatment initiation relative to the control arm. Treatment initiation is defined as initial mental health appointment being completed. |
An average of 30 weeks
|
|
Effectiveness of Intervention as Assessed by Rate of Depression Treatment Adherence
기간: An average of 30 weeks
|
The investigators will evaluate number of mental health treatment sessions completed relative to the control arm. Treatment adherence is defined as continuing treatment past initiation. |
An average of 30 weeks
|
|
Emotional Awareness
기간: An average of 30 weeks
|
Emotional awareness will be derived based on statistical modeling. |
An average of 30 weeks
|
|
Social Connectedness Scale
기간: Week 1 and an average of 30 weeks
|
Sense of Connectedness. On a scale from 0-10, how connected do you feel to the mental health service at your VA? Please write about your experience with Mental Health Link (MHL) that may have affected your sense of connectedness to the VA mental health service. |
Week 1 and an average of 30 weeks
|
|
Client Satisfaction Questionnaire
기간: Week 1 and an average of 30 weeks
|
Satisfaction with services. The Client Satisfaction Questionnaire consists of eight items, each rated on a 4-point Likert scale ranging from negative to positive responses (e.g., 1 = none of my needs met, 4 = almost all of my needs met). |
Week 1 and an average of 30 weeks
|
|
Barriers and Facilitators of Mental Health Link (MHL) Future Implementation
기간: An average of 30 weeks
|
Barriers and facilitators of Mental Health Link (MHL) future implementation will be assessed through qualitative interviews with Veterans and mental health providers. |
An average of 30 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Vanessa Panaite, PhD, Edward Hines Jr. VA Hospital, Hines, IL
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HSR4-024-25W
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .